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Trial record 62 of 132 for:    "Paroxysmal Ventricular Fibrillation"

VF Mapping in Brugada and Early Repolarization Syndromes

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ClinicalTrials.gov Identifier: NCT03764592
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
University of Bordeaux
Information provided by (Responsible Party):
Koonlawee Nademanee, MD, Pacific Rim Electrophysiology Research Institute

Brief Summary:
To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with BrS and Early Repolarization.

Condition or disease Intervention/treatment
Brugada Syndrome Early Repolarization Syndrome Other: radiofrequency ablation

Detailed Description:
The investigators will study symptomatic BrS and ERs syndrome (N=25) and asymptomatic patients (N=25) age between 16-70 years old to determine values and limitations of non-invasive mapping using electrocardiographic imaging (ECGI) in identifying VF substrates as target sites for catheter ablations in patients with Brugada (BrS) and Early repolarization syndromes (ERS) and also determine the mechanisms of VF in BrS and ERs syndromes.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mapping of Ventricular Fibrillation (VF) Substrates and VF Arrhythmogenic Sources/Reentrant Circuits in Patients With Brugada and Early Repolarization Syndromes
Actual Study Start Date : February 23, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020


Group/Cohort Intervention/treatment
VF BrS/ERS patients
Only patients that diagnosed with BrS or ERS based on ECG criteria
Other: radiofrequency ablation
Symptomatic patients whose substrates were identified will undergo catheter ablation; asymptomatic patients will be followed without undergoing catheter ablation.




Primary Outcome Measures :
  1. VF death [ Time Frame: 3 years ]
    ventricular fibrillation



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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Brugada marker or early repolarization marker on ECG.
Criteria

Inclusion Criteria:

Patients presenting with the type1 BrS ECG or ER ECG signature pattern, with/without a sodium channel blocker. Patients with the following one of these symptoms or arrhythmias will be considered as symptomatic patients: 1) aborted cardiac arrest cases, 2) documented VF episodes, 3) agonal respiration during sleep with difficulty to arouse, 4) syncope of unknown origin, or 5) seizure suspected of arrhythmic origin.•

Exclusion Criteria:

Patients who refuse informed consent and to participate to the best ability in the study.

Patients who have structural heart disease or concomitant medical illness.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764592


Contacts
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Contact: Carla Drew, BS 13104302613 carla@pacificrimep.com
Contact: Koonlawee Nademanee, MD 66870708787 wee@pacificrimep.com

Locations
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Thailand
Bumrungrad International Hospital Recruiting
Bangkok, Thailand
Contact: Koonlawee Nademanee, MD         
Principal Investigator: Koonlawee Nademanee, MD         
Pacific Rim Electrophysiology Research Institute Data Coordinating Center Recruiting
Bangkok, Thailand
Contact: Koonlawee Nademanee, MD    66870708787    koonlawee@pacificrimep.com   
Principal Investigator: Koonlawee Nademanee, MD         
Sponsors and Collaborators
Pacific Rim Electrophysiology Research Institute
University of Bordeaux
Investigators
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Principal Investigator: Koonlawee Nademanee, MD Chulalongkorn University

Publications of Results:
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Responsible Party: Koonlawee Nademanee, MD, Principal Investigator, Pacific Rim Electrophysiology Research Institute
ClinicalTrials.gov Identifier: NCT03764592     History of Changes
Other Study ID Numbers: PACIFICReri2
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Ventricular Fibrillation
Brugada Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn